Phase II Study of Oral Tegafur/Uracil and Leucovorin plus Bevacizumab as a First-Line Therapy for Elderly Patients with Advanced or Metastatic Colorectal Cancer.

Abstract

BACKGROUND/OBJECTIVE:

Oral tegafur/uracil and leucovorin (UFT/LV) therapy is effective and safe for elderly patients with advanced or metastatic colorectal cancer (CRC). However, there are few studies on the combination of bevacizumab with UFT/LV. This clinical study evaluated the efficacy and safety of UFT/LV plus bevacizumab as a first-line therapy for elderly patients with advanced or metastatic CRC.

METHODS:

Forty patients with advanced or metastatic CRC aged ≥ 75 years were enrolled in this multicenter, open-label, single-arm phase II study. All patients received oral UFT (300-600 mg) and LV (50 mg) twice daily on days 1-21 and intravenous bevacizumab (5 mg/kg) on days 1 and 15 of a 4-week cycle (University Hospital Medical Information Network No. UMIN000003447).

RESULTS:

The median follow-up period was 14.7 months. The response rate was 20.0% [95% confidence interval (CI): 9.1-35.6], median progression-free survival was 8.9 months (95% CI: 5.3-11), and median overall survival was 21.7 months (95% CI: 13.7-23.4). The only grade 3 hematological toxicity was neutropenia (3.0%), and the incidence rates of grade 3 nonhematological toxicity were low at ≤ 10%.

CONCLUSION:

UFT/LV plus bevacizumab is a promising first-line regimen for elderly patients with advanced or metastatic CRC. The combination is well tolerated and efficacious.

• Authors: Tsunekazu Mizushima, Hiroshi Tamagawa, Chu Matsuda, Kohei Murata, Mutsumi Fukunaga, Hirofumi Ota, Junichi Hasegawa, Masaki Tsujie, Takayuki Fukuzaki, Taishi Hata, Ichiro Takemasa, Masataka Ikeda, Hirofumi Yamamoto, Mitsugu Sekimoto, Riichiro Nezu, Yuichiro Doki, Masaki Mori
• Journal: Oncology (Oncology) Vol. 89 Issue 3 Pg. 152-8 ( 2015) ISSN: 1423-0232 [Electronic] Switzerland
• PMID: 25967649 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: © 2015 S. Karger AG, Basel.

Chemical References

• Antibodies, Monoclonal, Humanized
• Tegafur
• Bevacizumab
• Uracil
• Leucovorin

Topics

• Administration, Oral
• Aged
• Antibodies, Monoclonal, Humanized (administration & dosage)
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use)
• Bevacizumab
• Colorectal Neoplasms (drug therapy, pathology)
• Disease-Free Survival
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Humans
• Infusions, Intravenous
• Japan
• Kaplan-Meier Estimate
• Leucovorin (administration & dosage)
• Male
• Neutropenia (chemically induced)
• Tegafur (administration & dosage)
• Treatment Outcome
• Uracil (administration & dosage)